ENDOWAVE INFUSION SYSTEM— 510(k) K073166

Name: FDA 510(k) clearance K073166
Creator: U.S. Food and Drug Administration
Published: 2008-04-22

Unknown

Ekos Corp.

FDA 510(k) clearance K073166 for ENDOWAVE INFUSION SYSTEM, Unknown on 2008-04-22. Applicant: Ekos Corp.. Device class: 2.

Clearance details

Applicant: Ekos Corp.
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2007-11-09
Decision date: 2008-04-22
Decision: Unknown
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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K243534 — Micro Catheter2025-07-30

More clearances from Ekos Corp.

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K081467 — EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION2008-06-26
K080392 — EndoWave Infusion System2008-04-30
K072507 — ENDOWAVE INFUSION SYSTEM2007-10-04
K071933 — ENDOWAVE INFUSION SYSTEM2007-08-10
K063620 — EKOS MICRO-INFUSION SYSTEM2007-08-06

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.